FDA.reportPublic FDA data

Application 075757

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075757-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28
A075757-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075757-001AB
A075757-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28a50c72e98297…
2026-08-01 22:54:322026-06A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075757-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075757-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacydb9f071b-85f4-061f-e053-2995a90a3ff52026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
ndc (product): 60760-868
OmeprazoleOMEPRAZOLEQPharma Incf6f6ad19-ff6a-7cd3-e053-6294a90ae1bf2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCf76c23d5-26b6-cfb2-e053-6294a90aea422026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.0fb314cb-6291-422c-98ff-24d8449992f62025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEChartwell RX, LLC4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e2025-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLESandoz Inc516170d4-4913-4577-a2d2-f5c52d1e79c62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
ndc (product): 0781-2868
ndc (product): 0781-2859
OmeprazoleOMEPRAZOLEProficient Rx LPee0598a1-0e5e-40ff-ad88-b0adfc533ca02024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEBryant Ranch Prepack17664f71-154a-47c6-b83c-b349bbc8a98f2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
ndc (product): 71335-9609
OmeprazoleOMEPRAZOLESandoz Ince4562da8-9d94-4417-9f80-c1ffd42472592023-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
ndc (product): 0781-2790
ndc (product): 0781-2785

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1359OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7933OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7933OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8320OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8320OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8320OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2785OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2790OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2859OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
0781-2868OmeprazoleOmeprazoleSandoz IncANDACurrent
50090-2901OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-868OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
67046-700OmeprazoleOmeprazoleContract Pharmacy Services-PAANDACurrent
68071-2655OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0905OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-0905OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1019OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-1019OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-2295OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70934-335OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-335OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-335OmeprazoleOmeprazoleDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-0559OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
71335-9609OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent